AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) in Atopic Dermatitis
AbbVie Inc. (ABBV)
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Source: PR Newswire
NORTH CHICAGO, Ill., Oct. 19, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for RINVOQ™ (upadacitinib) for the treatment of adults (15 mg and 30 mg, once daily) and adolescents (15 mg, once daily) with moderate to severe atopic dermatitis. The atopic dermatitis indication applications to the FDA and EMA are supported by data from three pivotal Phase 3 studies. RINVOQ was studied without topical corticosteroids (TCS) in Measure Up 1 and Measure Up 2 and with TCS in AD Up.1-3 In all three studies, RINVOQ demonstrated significant improvement in skin clearance and reduction in itch in adults and adolescents with moderate to severe atopic dermatitis compared to placebo.1-3 RINVOQ met the co-primary endpoints including at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator's Global
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